AltoStar® BKV PCR Kit 1.5

 

IVD 2022 (AS0031543)

 

In the course of the forthcoming date of application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® BKV PCR Kit 1.5 has received a new product number and Global Trade Item Number (GTIN). The new product number reflects the desired change in regulatory status. All other product characteristics as well as the product performance remain unchanged. The kit is chemically identical to its already existing counterpart and contains the same kit components.

Products not FDA cleared or approved. Kits not available in all countries.

Key features

  • Detection and quantification of BK virus (BKV) specific DNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD plasma 66 IU/ml
LoD whole blood 105 IU/ml
LoD urine
21 IU/ml

 

 

 

Sample types

The following sample types are validated for use with the AltoStar® BKV PCR Kit 1.5:

 

Human EDTA plasma

Human citrate plasma

Human EDTA whole blood

Human citrate whole blood

Human urine

Other workflows

The AltoStar® BKV PCR Kit 1.5 can be used with compatible workflows (manual or automated). Real-time PCR instruments that have been validated for use with the AltoStar® BKV PCR Kit 1.5 are:

 

CFX96Deep Well Dx System (Bio-Rad)

CFX96 Dx System (Bio-Rad)

ABI Prism® 7500 SDS (Applied Biosystems)

LightCycler® 480 Instrument II (Roche)

QuantStudio5 Real-Time PCR System (Applied Biosystems)

Rotor-Gene® Q5/6 plex Platform (QIAGEN)

 

The AltoStar® BKV PCR Kit 1.5 can be used with nucleic acid extraction systems other than the AltoStar® AM16. Alternative procedures used for nucleic acid extraction have to be validated by the user.

Intended use

The AltoStar® BKV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of BK virus (BKV) specific DNA in human plasma, whole blood and urine. It is intended to be used as an aid for diagnosis of BKV infection and for monitoring of the BKV load in individuals with BKV infection.

AltoStar® BKV PCR Kit 1.5

Order No.AS0031543
Rxns96
TransportationDry ice
Regulatory statusCE-IVD

AltoStar® BKV PCR Kit 1.5

Gebrauchsanweisung AltoStar® BKV PCR Kit 1.5

pdf
File size: 2.88 MB
Veröffentlichungsdatum: 03/2022
Regulatorischer Status: CE-IVD

Instructions for use AltoStar® BKV PCR Kit 1.5

pdf
File size: 2.93 MB
Release date: 03/2022
Regulatory status: CE-IVD

Mode d'emploi AltoStar® BKV PCR Kit 1.5

pdf
File size: 3.07 MB
Date de sortie: 03/2022
Statut réglementaire: CE-IVD

Instruções de uso AltoStar® BKV PCR Kit 1.5

pdf
File size: 3.05 MB
Fecha de lanzamiento: 03/2022
Situación reglamentaria: CE-IVD

Instruções de Utilização AltoStar® BKV PCR Kit 1.5

pdf
File size: 3.04 MB
Data de lançamento: 03/2022
Estatuto regulamentar: CE-IVD

Istruzioni per l'uso AltoStar® BKV PCR Kit 1.5

pdf
File size: 3.02 MB
Data di rilascio: 03/2022
Stato normativo: CE-IVD

AltoStar® BKV PCR Kit 1.5

Konformitätserklärung/Declaration of conformity/Déclaration de conformité (DE, EN, FR)

pdf
File size: 321.45 KB
Veröffentlichungsdatum/Release date/ Date de sortie: 22.10.2021
Regulatorischer Status/Regulatory status/Statut réglementaire: CE-IVD

Declaración de conformidad/Dichiarazione di conformità/Declaração de conformidade (ES, PT, IT)

pdf
File size: 325.48 KB
Fecha de lanzamiento/Data di rilascio/Data de lançamento: 22.10.2021
Situación reglamentaria/Stato normativo/Estatuto regulamentar: CE-IVD